Search Results

The Lares Research 557 and 757 ProStyle model product family of high-speed handpieces is intended to be used by licensed dental professionals to reduce hard tooth structure, carry out cavity preparations and perform restorative dentistry.

The Lares Research 557 and 757 ProStyle model product family of high-speed handpieces are the next generation of the Lares high-speed handpiece product line. The Lares Research 557 and 757 ProStyle model product family of highspeed handpieces are substantially similar to the 557 Turbo+ and 757 Workhorse as they are light weight, air-driven high-speed turbine dental drills connected to standard ISO 9168 Type 2 and Type 3 dental unit hose connections. The Lares Research 557 and 757 ProStyle model product family of high-speed handpieces features include a solid glass fiber optic element and optional Kavo Multi-Flex compatible swivel quick connection.

This document describes the premarket notification (510(k)) for the Lares Research 557 and 757 ProStyle model product family of high-speed handpieces. The document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a standalone study with a defined ground truth.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a formal table of acceptance criteria with corresponding device performance metrics in the way one might expect for a diagnostic or AI device. Instead, it relies on a comparison of technological characteristics and compliance with a general standard.

Study Proving Device Meets Acceptance Criteria:

The study presented is a nonclinical performance test to demonstrate compliance with the ISO 14457: 2012 standard for air-driven high-speed dental handpieces.

• Acceptance Criteria for this study: The device must pass "all the applicable tests of ISO 14457: 2012." The specific tests within ISO 14457:2012 are the de facto acceptance criteria. The document states that the device "passed all the applicable tests."

2. Sample Size for the Test Set and Data Provenance:

• Test Set Sample Size: "master device samples of the Lares Research 557 and 757 ProStyle model product family of high-speed handpieces." This typically means a small number of physical units (e.g., 1-3 of each model) used for testing to the standard. It is not a statistically powered clinical trial sample size.
• Data Provenance: The tests were conducted on the manufactured samples of the new device. This is a prospective test specifically for this premarket notification. The document does not specify a country of origin for the testing, but the manufacturer is US-based (Chico, California).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• N/A. For this type of device (dental handpiece) and the nonclinical performance testing, the "ground truth" is adherence to the technical specifications and performance requirements outlined in the ISO 14457: 2012 standard. This is determined by engineering measurements and performance tests, not by expert consensus on, for example, image interpretation. There were no human experts involved in establishing a "ground truth" related to diagnostic accuracy.

4. Adjudication Method for the Test Set:

• N/A. There was no adjudication method in the sense of reconciling differences in expert opinions, as the assessment was based on objective physical measurements and adherence to technical standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. An MRMC study is not applicable to a high-speed dental handpiece. This type of study is used for diagnostic devices, particularly those involving human interpretation of data (e.g., radiologists reviewing images) to assess the impact of an AI tool on human performance.

6. Standalone Performance Study:

• Yes, implicitly. The nonclinical tests conducted in accordance with ISO 14457: 2012 represent a standalone performance evaluation of the device itself, without human-in-the-loop, against established engineering and safety standards for dental handpieces.

7. Type of Ground Truth Used:

• Engineering and Safety Standards / Technical Specifications: The ground truth for this device's performance evaluation against the ISO standard is derived from objective physical measurements and compliance with the defined limits and test methods specified in ISO 14457: 2012. For biocompatibility, the ground truth would be established by relevant ISO standards (e.g., ISO 10993 series), and for sterilization, by validated methods specific to sterilization.

8. Sample Size for the Training Set:

• N/A. This device does not involve machine learning or AI that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:

• N/A. As there is no training set, this is not applicable.

Ask a specific question about this device